Challenges

• Design a complete system of Lumbar IBFD’s and associated instruments for a startup company.
• Provide detailed designs and documentation required for FDA approval and product release.
• Collaborate with surgeons to determine feasibility of new ideas for the development of additional spine product lines.

Solutions

• Design a complete system of lumbar IBFD implants and associated implant-specific and discectomy instruments to meet requirements of product manager and collaborating surgeons.
• Perform testing, tolerance analyses and FEA in support of FDA approval and product release.
• Determine feasibility of 11 collaborative projects with surgeons by creating initial designs, making prototypes and estimating clinical effectiveness, cost, time and project scope.

Benefits

• Release a complete spine system from concept through manufacturing with outstanding clinical results, fast time to market, and minimal development cost.

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